TriangleNCT02684006 · OUTCOME
Time to Symptom Deterioration (TTD) for Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- Date of randomization to the first time the participant's score showed a 3-point or greater decrease in FKSI-DRS (maximum up to approximately 26 months)
What was measured
TTD was defined as the time from date of randomization to the first time the participant's score showed a 3-point or greater decrease in FKSI-DRS. FKSI was used to assess symptoms and quality of life (QoL) for those diagnosed with advanced kidney cancer and it consisted of 19 questions. A 9-item subscale of the FKSI known as FKSI-Disease Related Symptoms subscale (FKSI-DRS). This subscale included 9 items: lack of energy, pain, losing weight, bone pain, fatigue, shortness of breath, coughing, bothered by fevers, and hematuria. Each of the 9 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptoms) to 36 (very much); higher score indicated greater presence of symptoms.
Analysis population: FAS included all randomized participants.
Groups in this outcome
Avelumab + Axitinib
Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.
Sunitinib
Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
| Group | Source count |
|---|---|
| Avelumab + Axitinib | 442 |
| Sunitinib | 444 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Avelumab + Axitinib | 4.2 | Not reported | 4.2 | 5.7 | Not reported |
| Sunitinib | 6.3 | Not reported | 5.5 | 8.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.2
- upper Limit
- 5.7
- value
- 4.2
- group Id
- OG001
- lower Limit
- 5.5
- upper Limit
- 8.3
- value
- 6.3
- denoms
- counts
- group Id
- OG000
- value
- 442
- group Id
- OG001
- value
- 444
- units
- Participants
- description
- TTD was defined as the time from date of randomization to the first time the participant's score showed a 3-point or greater decrease in FKSI-DRS. FKSI was used to assess symptoms and quality of life (QoL) for those diagnosed with advanced kidney cancer and it consisted of 19 questions. A 9-item subscale of the FKSI known as FKSI-Disease Related Symptoms subscale (FKSI-DRS). This subscale included 9 items: lack of energy, pain, losing weight, bone pain, fatigue, shortness of breath, coughing, bothered by fevers, and hematuria. Each of the 9 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptoms) to 36 (very much); higher score indicated greater presence of symptoms.
- dispersion Type
- Full Range
- groups
- description
- Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.
- id
- OG000
- title
- Avelumab + Axitinib
- description
- Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
- id
- OG001
- title
- Sunitinib
- param Type
- MEDIAN
- population Description
- FAS included all randomized participants.
- reporting Status
- POSTED
- time Frame
- Date of randomization to the first time the participant's score showed a 3-point or greater decrease in FKSI-DRS (maximum up to approximately 26 months)
- title
- Time to Symptom Deterioration (TTD) for Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice